Readers who’d like to set down and then put their Good Supply Practices (GSPs) in motion, practice the core concepts that need to surround that effort, and align both internally and externally for a more successful supply-chain experience, might want to look over this well-worth-the-wait report.
With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.
In this two-part article, FDA Supervisory Consumer Safety Officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 Program Director Art Czabaniuk, and OPQO Division 3 Investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. Part 1 unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.
Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?
Why it does, and how one startup is winning the biotech talent wars with a diversity-centric strategy.
Project execution and project management are probably two of the topics that are most written about but least understood by the biopharmaceutical industry. This article is not about the theory of management, but it is a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.
Heart failure with preserved ejection fraction (HFpEF) remains one of the greatest and most challenging unmet needs in cardiovascular (CV) medicine. In contrast to the significant advances being made in the treatment of heart failure with reduced ejection fraction (HFrEF), little has changed in the approach to treating HFpEF in decades. The lack of effective treatment options is not due to the lack of pipeline activity in this indication but rather due to the 100 percent failure rate of late-stage clinical trials. What is the recipe for designing HFpEF trials with the best chance of success? There are several important considerations.
The Institute for Clinical and Economic Review (ICER) recently conducted a study of value assessment methods considered for “cures” or “potential cures” and solicited input from international HTA bodies. The research will form the basis of a value framework that will be applied in the assessment of potential cures and other treatments that qualify as what ICER refers to as “single or short-term transformative therapies.”
Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.
This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.
Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.
Are we dangerously reliant on outsourcing to China, and is this outsourcing without the good of U.S. patients in mind? Our drug development and manufacturing outsourcing industry can’t escape the ins-and-outs of geopolitical and global affairs. Learn more in this free collection of articles
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